茶多酚减肥胶囊中表没食子儿茶素没食子酸酯含量测定方法学研究  

Method Validation Experimental Study for the Determination of Functional Ingredient in Tea Polyphenols Jianfei Capsules

作　　者：郑海云[1] 王少南 赵海誉[2] 张雯[1] 李光敏 王斌[1] ZHENG Hai-Yun;WANG Shao-Nan;ZHAO Hai-Yu;ZHANG Wen;LI Guang-Min;WANG Bin(Chinese Medicine Science and Technology Cooperation Center,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Traditional Chinese Medicine,China Academy of Traditional Chinese Medicine,Beijing 100700,China)

机构地区：[1]中国中医科学院中医药科技合作中心,北京100700 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国药物经济学》2024年第11期92-96,共5页China Journal of Pharmaceutical Economics

基　　金：中国中医科学院科技创新工程项目(CI2021A04510)。

摘　　要：目的设计茶多酚减肥胶囊中功效成分表没食子儿茶素没食子酸酯(EGCG)含量测定方法学验证综合实验,为茶多酚减肥胶囊的质量控制和功效成分含量测定奠定基础。方法参考GB/T31740.2-2015中EGCG的测定方法,以十八烷基硅烷键合硅胶为填充剂,流动相为1%冰醋酸-乙腈进行梯度洗脱,检测波长为278nm,柱温25℃,进行检测,以峰面积外标法定量。结果在选定的色谱条件下,其专属性、线性、精密度、准确度、稳定性符合要求。结论经过方法学验证,本法简便快捷、准确度高、重复性好,是检测茶多酚减肥胶囊中EGCG的有效定量方法。Objective To establish the determination of EGCG in Tea Polyphenols Jianfei capsules by HPLC.Methods Consulting GB/T 31740.2-2015 and experiments,using 1%Acetic acid and Acetonitrile as mobile phase,gradient elution,column temperature was 25℃,separated by Carotenoid column,detected by HPLC with UVD at 278 nm,and quantified by the external standard method.Results Method validation included exclusivity,linearity,precision,accuracy and stability,which laid the foundation for the control the quality and assay the content of functional ingredient in Tea Polyphenols Jianfei capsules.Conclusion The method is simple,rapid and accurate,which can be applied to the analysis of the content of EGCG in Tea Polyphenols Jianfei capsulles.

关 键 词：含量测定 表没食子儿茶素没食子酸酯 方法学验证 

分 类 号：R927.2[医药卫生—药学]